The present invention relates generally to anastomosis, and more particularly to a set of tools and a functional package for preparing a graft vessel for anastomosis.
Anastomosis is a procedure where two separate tubular or hollow organs are surgically grafted together to form a continuous fluid channel between them. Vascular anastomosis involves creating an anastomosis between blood vessels to create or restore blood flow. When a patient suffers from coronary artery disease (CAD), an occlusion or stenosis in a coronary artery restricts blood flow to the heart muscle. In order to treat CAD, the area where the occlusion occurs is bypassed to reroute blood flow by grafting a vessel in the form of a harvested artery or vein, or a prosthesis. Anastomosis is performed between a graft vessel and two target vessels in order to bypass the blocked coronary artery, circumvent the occlusion and restore adequate blood flow to the heart muscle. This treatment is known as a coronary artery bypass graft procedure (CABG).
In a CABG procedure, a graft vessel such as a saphenous vein, mammary artery, radial artery or other blood vessel is harvested from the patient or another source, then placed in a bowl or other container and immersed in saline, blood or other biocompatible liquid. Before that graft vessel is connected to the target vessels, it may be prepared in some way, such as by connecting it to an anastomosis device and/or a tool for applying the anastomosis device. The graft vessel is typically connected to the anastomosis device and/or tool manually by one or more people in the operating room, using forceps, tweezers and/or other tools. Substantial skill is required to connect the slippery graft vessel to the anastomosis device and/or tool without damaging the graft vessel or otherwise rendering it unusable.
A system for preparing a graft vessel for anastomosis includes one or more tools held within a functional package.
In one aspect of the invention, a functional package includes a tray having multiple recesses. The package can be sealed, and sterilized along with its contents. The recesses are used to hold one or more tools for preparing a graft vessel for anastomosis. The tray includes one or more recesses or other features molded into it that allow for storing a graft vessel in a biocompatible fluid such as blood or saline solution, for moving one or more tools relative to one another, or for performing other functions that would otherwise be handled by additional tools, trays, bowls or other items. Thus, the package reduces waste and operating room clutter.
In another aspect of the invention, an assembly for receiving a vein graft is held in a recess in the package. The assembly includes a crown, an anastomotic device that is connected to one end of the crown, and an expander tube within the crown. The crown may be connected to a cartridge or other structure. The package holds the crown snugly, which in turn holds the expander tube. The package holds the assembly while a graft vessel is loaded onto it.
In another aspect of the invention, a pull-through tool includes a handle connected to a tension member. The handle is held in a recess in the package, and the tension member is prepositioned within and slidable through the crown. At least one grasping element is connected to the tension member. When the tension member is in a first position, at least one grasping element is configured to receive an end of a graft vessel. When the tension member is moved to a second position, at least one grasping element is configured to compress or puncture the end of the graft vessel, thereby holding the graft vessel. The tension member is pulled into one end of the expander and crown, carrying the graft vessel with it. After a preselected length of the graft vessel has been pulled out of the other end of the crown, the graft vessel is cut to release it from the grasping element or elements. The pull-through tool thus allows for simple loading of a graft vessel through the crown and expander tubes and onto the anastomotic device.
In another aspect of the invention, a detachable eversion shield is held in the package, covering at least part of the anastomotic device. The anastomotic device includes barbs or sharp tips, which are covered by the eversion shield to provide a substantially continuous smooth surface onto which an end of the graft vessel can be everted. The eversion shield is then removed from the crown.
In another aspect of the invention, a poke-through tool is held in a recess in the package. The poke-through tool includes a membrane through which tines or sharp tips of the anastomotic device can penetrate, such that contact between the membrane and the end of the graft vessel pushes the graft vessel down onto the tines to fully engage them, thereby preparing the graft vessel for deployment. A channel in the package may be configured to receive a portion of the poke-through tool and guide the travel of the poke-through tool relative to the crown. The channel substantially prevents rotation of the poke-through tool during its translation relative to the anastomotic device, and is positioned such that motion of the poke-through tool along the entire length of the channel ensures that the poke-through tool has pushed the graft vessel onto the tines of the anastomosis device. Thus, the channel provides for better control of the poke-through tool. The poke-through tool also may be used to release the eversion shield from the anastomosis device.
In another aspect of the invention, the prepared graft vessel is immersed in a biocompatible fluid, such as saline solution or blood, within a recess in the tray. This may be the same recess in which the crown, expander tube and anastomosis device were originally held, or another recess in the tray. The graft vessel is then available for use in an anastomosis tool or other device as needed. By using the package to immerse and hold the prepared graft vessel, the preparation process is simplified, and the number of fluid containers used is reduced.
In another aspect of the invention, an anastomosis tool is held in a recess in the package. After the graft vessel has been prepared, the assembly is removed from the package and the crown, expander tube and graft vessel are inserted into an appropriate passage within the anastomosis tool. A removable guide may be held in the integrated anastomosis tool to facilitate insertion of the crown, expander tube and graft vessel, and is removed after the anastomosis tool has received at least a portion of the crown, expander tube and graft vessel.